CONTROL-IHD Study: 24-h BP Control with Metoprolol-Telmisartan FDC in Hypertension and Stable Ischemic Disease

Optimal blood pressure (BP) control is essential in ischemic heart disease (IHD) to reduce cardiovascular risk. Current guidelines recommend fixed-dose combinations (FDCs) to enhance efficacy, patient adherence, and compliance. The study aimed to evaluate the efficacy and tolerability of metoprolol succinate extended-release 25/50 mg and telmisartan 40 mg FDC (Metosartan®) in patients with essential hypertension and stable IHD, using ambulatory BP monitoring (ABPM). This open-label, single-arm, multicentric, Phase IV study enrolled 88 patients who received Metosartan® once daily (OD) for 8 weeks. Primary endpoint was change in mean 24-h systolic and diastolic BP (SBP, DBP) on ABPM from baseline to week 8. Secondary endpoints included responder rates, changes in mean heart rate (HR), short-term BP variability (BPV), 24-h distribution of BP reduction, and safety outcomes. Seventy-two patients completed the study. The FDC significantly reduced 24-h mean ABPM-measured SBP (143.38 ± 12.55 mmHg to 129.03 ± 11.77 mmHg) and DBP (88.84 ± 8.12 mmHg to 79.34 ± 7.93 mmHg) over 8 weeks. Mean reductions were – 14.41 ± 14.69 mmHg and – 9.52 ± 9.96 mmHg, for SBP and DBP, respectively ( p < 0.0001). The ABPM-based responder rate was 36.62% (26/71). HR and 24-h BP indices improved significantly. From Weeks 2–4 to Week 8, the smoothness index increased by 0.15 (SBP) and 0.11 (DBP), while the treatment on variability index increased (TOVI) by 0.20 (SBP) and 0.16 (DBP) (all p < 0.0001). Short-term BPV showed mixed findings. Treatment was well tolerated, with only mild adverse events reported. Metosartan® demonstrated effective and sustained 24-h BP reduction and good tolerability in Indian patients with hypertension and stable IHD. The reductions observed during the early post-application and late dosing-interval periods suggest sustained BP lowering over 24 h. Clinical Trials Registry India, CTRI/2022/09/045464